Senior QC Analyst

Location
Redwood City, CA, USA
Posted
Dec 07, 2018
Ref
EB-6132617606
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
As a member of the Bulletproof family, you'll enjoy a culture that values diversity in all things - people, work, experience levels, and much more. We tackle the toughest challenges, produce impactful results, and build solid client relationships along the way - with energy, passion, and fun. If this sounds like a good fit for you, please consider this exciting opportunity with our firm!

Overview:
Manage method transfer process effectively to deliver analytical methods from one site to another. Coordinate validation and testing activities for release, stability and in-process methods to support the manufacture of product suitable for FDA and other regulatory agency licensure. The position reports to Director of Quality Control.

Principle Responsibilities and Duties:
• Manage method transfers and validation activities between Analytical Labs and Contract Testing Laboratories ( CTLs), Contract Manufacturing Operations Laboratories. Recommend revalidation or new methods when appropriate
• Review assay validation protocols, data, and reports.
• Support stability report writing.
• Prepare and/or assist in writing regulatory submissions ( IND, BLA, MAA)
• Provide creative/innovative solutions to increase operational efficiency and contribute to the on-going business process improvements
• Review data for Certificate of Analysis.
• Ensure validated state of methods and periodically review their performance. Document the overall review of methods and address gaps. Proposes requalification or revalidation of methods
• Lead or participate in Quality and Compliance initiatives.
• Ensure the maintenance of compliant QC systems including documentation with CTLs and CMOs.
Experience, Education, Training, Traits:
• Bachelor degree in Sciences, or comparable experience, and more than 3 years of progressive responsibility in a GMP environment
• Experience in a variety of analytical techniques including HPLC, electrophoresis, and spectroscopy to determine the purity and impurity profiles of proteins
• Hands-on experience with method development, validation and transfer in support of pharmaceutical manufacturing
• Exceptional attention to detail
• Exercise sound and independent judgment
• Strong project management, collaboration and organization skills
• Excellent written and oral communications skills
• Listening, interpreting and summarizing information with clear and concise verbal communication